Uro-G Cystoscope
K-Number: K202921 · 2021-05-04
ApplicantUroviu Corporation
Decision Date2021-05-04
Product CodeFAJ
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Uro-G Cystoscope is a medical device manufactured by Uroviu Corporation. It received FDA 510(k) clearance on 2021-05-04 under approval number K202921. The device is classified under product code FAJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Uro-G Cystoscope?
Uro-G Cystoscope is a medical device that received FDA 510(k) clearance on 2021-05-04. It is manufactured by Uroviu Corporation. The 510(k) number is K202921.
When was Uro-G Cystoscope approved by the FDA?
Uro-G Cystoscope received FDA 510(k) clearance on 2021-05-04, under approval number K202921.
What company makes Uro-G Cystoscope?
Uro-G Cystoscope is manufactured by Uroviu Corporation.
What is the FDA product code for Uro-G Cystoscope?
The FDA product code for Uro-G Cystoscope is FAJ.
Other Devices by Uroviu Corporation
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.